Introducing GMP, Root Cause Analysis and Understanding Validation Training Programme

Introducing GMP, Root Cause Analysis and Understanding Validation Training Programme can be delivered in a hotel, one of our offices, your premises or online via a virtual classroom. The course content can be tailored to meet your requirements. Request a quote for an onsite or online virtual course for an agreed number of delegates from your site.

The purpose of the Introducing GMP, Root Cause Analysis and Understanding Validation (3 Day) Training Programme is to provide learners with the opportunity of either taking one course alone, a mix of the following courses or all three in their entirety, over consecutive days.

The complete programme allows learners to build a basic knowledge of GMP through to gaining an insight into Root Cause Analysis, and then on to understanding the requirements for Validation in the Healthcare Industry.

The programme comprises Introducing GMP Training (Day 1), Root Cause Analysis Training (Day 2), and Understanding Validation Training (Day 3).

Day 1

• Understand the need for GMP
  • What is GMP?
  • GMP and its link with Quality Assurance and Quality Control
• Define the GMP guidelines and how agencies enforce them
  • What are the relevant regulations?
  • How the main regulatory agencies audit and enforce them
• Investigate the 4 Ps
  • People - adequacy, experience, training and the role of the Qualified / Responsible Person
  • Procedures and Documentation - from the completion of SOPs to in-process controls
  • Production Areas and Equipment - premises, layouts and considerations
  • Products and Components - incoming, handling, storage, packaging, labelling and non-conforming products
  • Identify potential GMP violations and their consequences
  • Use interactive case studies to analyse scenarios
  • Examine real reported incidents
• Determine behaviours that improve GMP
  • Plan for workplace improvements

Day 2

• Investigate what a non-conformance or deviation is
  • Terms, acronyms and their application
  • How to better define the problem or non-conformance or deviation situation or event
  • Consider misconceptions when defining the problem or non-conformance or deviation situation or event
• Reflect on regulatory expectations
  • Regulatory requirements
  • Common FDA and EU regulator inspection findings
• Investigate use of problem analysis to enable understanding and a structured and comprehensive approach
  • Techniques for date collection such as walk through, variance analysis, mitigation strategy analysis and interview best practice
  • Utilise risk management techniques
  • Review of different methods such as Cause and Effect, Flow and Process Charts, 5 Whys and others
  • Examine different types of causes including probable, contributing and actual root cause
  • Methods for verifying root cause
• Investigate the subject of Human Error
  • Review human characteristics and factors that could play a role in human error
  • Identify different types of human failure
  • Review ways of addressing human failure
• Apply and review non-conformance or deviation case studies to enhance course learning
  • Identify potential deviations and what needs to be done
  • Use different potential real activities to apply non-conformance or deviation

Day 3

• Investigate the history and requirements for validation
  • What is validation?
  • Regulatory requirements and expectations
• Understand the terms and the application of validation
  • Discuss the terms used
  • Evaluate the key stages of validation
  • Use the basic 'V' model for a simple approach
  • View a CD video and answer questions
  • How far does Good Engineering Practice go towards meeting compliance?
• Use case studies to explore the causes and implications of non compliant validation
  • Analyse real scenarios
  • Determine suitable actions for workplace improvements

ITS’ Regulatory Compliance Trainer, Dr Jennifer Thompson, has over 20 years of experience in the pharmaceutical sector in computer systems validation and IT infrastructure controls and compliance and has delivered projects for a wide range of companies in the UK, EU and USA including GlaxoSmithKline, Novartis Healthcare, Lonza Biologics, Elan Pharmaceuticals, Hoffman LaRoche and others. Her experience covers computerised systems used in manufacturing, laboratories, enterprise systems and clinical trials management. She has written articles and given presentations on a wide range of topics and contributed to the GAMP® Good Practice Guide “A Risk-based Approach to GxP Process Control Systems” and “The Risk Based Compliance Handbook” by Siegfried Schmitt (Paraxel).

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